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Ch. 20 - Recombinant DNA Technology
All textbooksKlug 12th EditionCh. 20 - Recombinant DNA TechnologyProblem 19
Chapter 19, Problem 19

Should the FDA regulate direct-to-consumer genetic tests, or should these tests be available as a 'buyer beware' product?

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1
span>1. Understand the context: Direct-to-consumer (DTC) genetic tests are those that can be purchased by consumers without the need for a healthcare provider. These tests can provide information about ancestry, health risks, and other genetic traits.</span
span>2. Consider the role of the FDA: The Food and Drug Administration (FDA) is responsible for protecting public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices. This includes regulating genetic tests to ensure they are accurate and reliable.</span
span>3. Evaluate the benefits of regulation: Regulation by the FDA could ensure that DTC genetic tests provide accurate and clinically valid results, reducing the risk of consumers making health decisions based on incorrect information.</span
span>4. Consider the 'buyer beware' approach: Without regulation, consumers would need to rely on their own judgment and research to assess the validity and reliability of genetic tests, which could lead to misinformation and potential harm.</span
span>5. Weigh the ethical and practical implications: Consider the balance between consumer autonomy and protection, the potential for misuse of genetic information, and the impact on public health.</span

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Key Concepts

Here are the essential concepts you must grasp in order to answer the question correctly.

Direct-to-Consumer Genetic Testing

Direct-to-consumer (DTC) genetic testing allows individuals to access their genetic information without the need for a healthcare provider. These tests can provide insights into ancestry, health risks, and traits, but they often lack comprehensive medical guidance. Understanding the implications of DTC testing is crucial, as results can lead to anxiety or misinterpretation without professional context.
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Regulatory Framework

The regulatory framework for genetic testing involves guidelines and policies that govern the safety, efficacy, and marketing of these tests. In the U.S., the FDA plays a key role in determining whether genetic tests require premarket approval. The debate centers on balancing consumer protection with innovation, as overly stringent regulations may stifle advancements in genetic technology.
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Informed Consent and Ethical Considerations

Informed consent is a fundamental ethical principle in healthcare, requiring that individuals understand the risks and benefits before undergoing testing. In the context of DTC genetic tests, consumers must be aware of potential privacy issues, the accuracy of results, and the implications of their genetic information. Ethical considerations also include the potential for discrimination based on genetic data and the need for clear communication from test providers.
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Related Practice
Textbook Question

To estimate the number of cleavage sites in a particular piece of DNA with a known size, you can apply the formula N/4ⁿ where N is the number of base pairs in the target DNA and n is the number of bases in the recognition sequence of the restriction enzyme. If the recognition sequence for BamHI is GGATCC and the  phage DNA contains approximately 48,500 bp, how many cleavage sites would you expect?

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Textbook Question

The National Institutes of Health created the Genetic Testing Registry (GTR) to increase transparency by publicly sharing information about the utility of their tests, research for the general public, patients, health-care workers, genetic counselors, insurance companies, and others. The Registry is intended to provide better information to patients, but companies involved in genetic testing are not required to participate. Should company participation be mandatory? Why or why not? Explain your answers.

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Textbook Question

In a typical PCR reaction, describe what is happening in stages occurring at temperature ranges (a) 92-26 °C, (b) 45-65 °C, and (c) 65-75 °C.

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Textbook Question

We usually think of enzymes as being most active at around 37°C, yet in PCR the DNA polymerase is subjected to multiple exposures of relatively high temperatures and seems to function appropriately at 65–75°C. What is special about the DNA polymerase typically used in PCR?

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Textbook Question

Would you have your genome sequenced, if the price was affordable? Why or why not? If you answered yes, would you make your genome sequence publicly available? How might such information be misused?

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Textbook Question

Traditional Sanger sequencing has largely been replaced in recent years by next-generation and third-generation sequencing approaches. Describe advantages of these sequencing methods over first-generation Sanger sequencing.

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